AKRON

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产品名称: AKRON

产品型号: **代理

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简单介绍

AKRON公司 AKRON代理 AKRON**代理 AKRON中国代理

AKRON 的详细介绍

AKRON公司 AKRON代理 AKRON**代理 AKRON中国代理

Company Overview

Founded in 2006, Akron Biotech is a privately owned company headquartered in South Florida, U.S., with a strategic focus on supplying technology, tools, and services to the regenerative medicine industry.

A global supplier, Akron manufactures and distributes components and raw materials for cell therapy discovery, development, and commercialization, meeting the industry’s needs worldwide. Our business model emphasizes flexibility, quality, and service. Akron works closely with its clients, from research and development through clinical trial, then on to market authorization and commercial product.

Capabilities and Services

Akron currently manufactures a range of proprietary products in its Boca Raton facility, with manufacturing capacity extending to sites in South America and Europe. Robust manufacturing and quality assurance systems are central to Akron’s success. We are set up to comply with cGMP, cGLP, USDA, FDA, CFR, and HIPPA regulations and standards.

Our Boca Raton manufacturing facility is ISO 9001 certified and FDA Device Registration is pending. In addition to filling vials, bags and syringes, our capabilities extend to manufacturing scaffolds and biomaterials for combinational products (containing both biologics and devices). We also provide process validation and release testing services, and recombinant protein expression and purification, including native protein extraction, under cGMP guidelines.

Our application-specific skills, combined with our advanced manufacturing capabilities, enable Akron to deliver complete packaged solutions to our customers.

Our established capabilities qualify us to provide custom products and a wide range of off-the-shelf items supporting the regenerative medicine industry. Our reagent offerings include recombinant proteins, available in both cGMP and research grades; sera and native purified proteins from human and multiple animal species; cell culture media; scaffolds; and novel proprietary cryopreservation formulations.

Akron’s services span the drug development pipeline. By providing all of our products in a range of grades, and by manufacturing in-house, we ensure the quality and consistency necessary to meet stringent international regulatory guidelines. We offer a range of services as well, including regulatory support and validation.

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